End Stage Renal Disease, Peritoneal Dialysis-associated Peritonitis
Conditions
Brief summary
A proof-of-concept study of a prototype CloudCath device designed to detect peritonitis using the effluent dialysate from patients undergoing peritoneal dialysis.
Interventions
DIAGNOSTIC_TESTEffluent dialysate
Effluent dialysate samples evaluated for evidence of peritonitis
Sponsors
CloudCath
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Males or females with end-stage renal disease on peritoneal dialysis for a minimum of 10 days prior to obtaining the specimen. * Specimens shall be leftover (or remnant) from a specimen that has been drained as part of the routine care for the patient. * Specimens shall not contain any individually identifiable information from the patient it was obtained from.
Exclusion criteria
* Patients providing specimens should not be under the administration of any antibiotics other than those utilized for the treatment of peritonitis. * Patients providing specimens should not suffer from a known liver disease or from ovarian or liver cancer. * Patients providing specimens should not be under the administration of calcium channel blockers or amlodipine for less than 30 days prior to providing a specimen.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Spectral measurements of effluent dialysate solutions | immediately post dialysis | a quantitative analysis of the spectral characteristics of the effluent dialysate solution using a proprietary algorithm and sensing equipment that results in a quantitative CloudCath Score. |
| Conductivity measurements of effluent dialysate solutions. | immediately post dialysis | a quantitative assessment of conductivity of the effluent dialysate solution using a proprietary algorithm and sensing equipment that results in a quantitative CloudCath Score. |
Countries
Mexico
Outcome results
None listed